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OncoMatch/Clinical Trials/NCT06732232

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma

Is NCT06732232 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CD19/CD20/BCMA CAR-T for relapsed.

Early Phase 1RecruitingShanghai Cell Therapy Group Co.,LtdNCT06732232Data as of May 2026

Treatment: CD19/CD20/BCMA CAR-TThis is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Biomarker criteria

Required: BCMA (TNFRSF17) antigen positive (including weak, moderate, or strong positive) (positive (including weak, moderate, or strong positive))

The bone marrow flow cytometry results showed positive BCMA antigen (including weak positive, moderate positive, and strong positive)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 3 prior lines

Must have received: anti-CD38 monoclonal antibody

Those who have received treatment with at least three different mechanisms of action (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed

Must have received: proteasome inhibitor

Those who have received treatment with at least three different mechanisms of action (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed

Must have received: immunosuppressant

Those who have received treatment with at least three different mechanisms of action (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed

Cannot have received: anti-CD45

Previously received any anti-CD45 or anti-CD3 treatment

Cannot have received: anti-CD3

Previously received any anti-CD45 or anti-CD3 treatment

Cannot have received: autologous hematopoietic stem cell transplantation

Exception: within 8 weeks of signing the ICF, or plan to undergo ASCT during the study period

Subjects who receive autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of signing the ICF, or who plan to undergo ASCT during the study period

Cannot have received: allogeneic stem cell therapy

Subjects who have received allogeneic stem cell therapy in the past

Cannot have received: investigational drug or systemic anti-tumor treatment

Exception: within 4 weeks (or 5 half lives of the drug, whichever the researcher deems more appropriate) prior to single collection

Received any investigational drug or systemic anti-tumor treatment within 4 weeks (or 5 half lives of the drug, whichever the researcher deems more appropriate) prior to single collection

Lab requirements

Blood counts

Lymphocyte count >0.5 × 10^9/L; Neutrophil count ≥ 1.0 × 10^9/L; Hemoglobin ≥ 60g/L; Platelets ≥ 40 × 10^9/L

Kidney function

24-hour serum creatinine clearance rate ≥ 30 mL/min

Liver function

AST and ALT ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 × ULN

Cardiac function

QTcF >470 ms excluded; NYHA Grade II and above heart failure excluded; LVEF ≤ 50% excluded; poorly controlled hypertension (SBP ≥ 150 mm Hg and/or DBP ≥ 95 mm Hg) excluded; clinically significant arrhythmias excluded

The blood biochemistry test results meet the following criteria: AST and ALT ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 × ULN; 24-hour serum creatinine clearance rate ≥ 30 mL/min; Lipase and amylase ≤ 2 × ULN. The blood routine test meets the following criteria: Lymphocyte count >0.5 × 10^9/L; Neutrophil count ≥ 1.0 × 10^9/L; Hemoglobin ≥ 60g/L; Platelets ≥ 40 × 10^9/L. Cardiovascular diseases with clinical significance, including any of the following: QTcF >470 ms; NYHA Grade II and above heart failure; LVEF ≤ 50%; poorly controlled hypertension (SBP ≥ 150 mm Hg and/or DBP ≥ 95 mm Hg); clinically significant arrhythmias

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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